Condition category
Pregnancy and Childbirth
Date applied
22/04/2009
Date assigned
29/06/2009
Last edited
29/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Atif Rahman

ORCID ID

Contact details

Child & Adolescent Psychiatry
School of Population
Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5509
atif.rahman@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Integration and evaluation of a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan: a cluster randomised controlled trial

Acronym

PROBE Study

Study hypothesis

The aim of this project is to provide the National Program for Family Planning and Primary Health Care of Pakistan and their Lady Health Workers (community health workers) with a well-researched, evidence-based intervention to promote exclusive breastfeeding, which has the potential for up-scaling. The objective of the project is to integrate a community-based exclusive breastfeeding promotion intervention into the routine work of Lady Health Workers, train them in using this approach, and to evaluate its effect on rates of exclusive breastfeeding.

Hypotheses:
Compared to mothers receiving standard breastfeeding advice by Lady Health Workers, mothers who receive the experimental intervention (also by Lady Health Workers) will:
1. Have a higher rate of exclusive breastfeeding (defined as giving maternal milk at the only infant food source in the previous week, with no other liquids or food given) at 6 months post-natally
2. Have a longer duration of exclusive breastfeeding
3. Have reduced levels of psychosocial distress

Ethics approval

Human Development Research Foundation, registered with the Office of Human Research Protections (OHRP), gave approval on the 10th December 2008 (ref: HDRF/IRB/002)

Study design

Cluster randomised single-blind parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breastfeeding

Intervention

The proposed study is a cluster randomised controlled trial with two parallel arms. The intervention arm will receive seven sessions of this maternal focused approach to promote breastfeeding through Lady Health Workers. The control arm will receive a similar number of visits of routine counselling for breastfeeding through different Lady Health Workers.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

All assessments will be carried out using instruments that have been translated, field-tested and validated in the local population through our previous work. Assessments will be carried out at baseline (third trimester), and prospectively for 6 months after birth.

Baseline measures:
1. Socioeconomic status (household income and assets)
2. Maternal age
3. Education
4. Body mass index
5. Scores of psychosocial distress on the Self-Reporting Questionnaire (SRQ)
6. Number of children
7. Family structure
8. Levels of post-traumatic stress and depressive reactions to the 2005 earthquake in the study area, assessed using the Earthquake Exposure Scale

Main outcome:
The duration of exclusive breastfeeding (EBF) and its rate at 6 months, measured prospectively using the following method: each mother enrolled into the study will be visited fortnightly by an independent team, blind to the allocation status of the mother, to record the breastfeeding status and practice in the last 24 hours. For this study, EBF was defined as: only breastfeeding being practiced with no other semi-solid or liquid foods (other than medication and/or oral rehydration solutions).

Secondary outcome measures

1. Psychological distress, measured at baseline, 3 and 6 months using the Self-Reporting Questionnaire (SRQ-20). This psychiatric screening instrument, which was developed specifically for use in primary care by health workers in developing countries, has 20 items with a 'yes' or 'no' response to questions about psychological and somatic symptoms in the past 30 days.
2. Rates and duration of predominant and partial breastfeeding, assessed at 6 months of infant's age prospectively using the above mentioned method
3. Process outcomes: studied qualitatively using key-informant interview and focus groups. At the 'system' level, the opinion of key personnel from the programme and primary health care (including LHWs), will be obtained on all aspects of training, delivery, usefulness and potential costs of the intervention (in terms of extra time and material needed to deliver the intervention). At the family level, we will obtain feedback from mothers and other significant family members about the intervention.

Overall trial start date

01/05/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Married, consenting women
2. Aged 17 - 40 years
3. Pregnant; in their 3rd trimester of pegnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

440 third trimester pregnant women

Participant exclusion criteria

1. A diagnosed medical or mental illness
2. Currently under treatment, e.g., tuberculosis, hepatitis B or C or a mental health illness

Recruitment start date

01/05/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Pakistan

Trial participating centre

Child & Adolescent Psychiatry
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

c/o Prof. Atif Rahman
Child and Adolescent Psychiatry
School of Population
Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Mulbery House
Eaton Road
Liverpool
L 12 2AP
United Kingdom
+44 (0)151 252 5509
atif.rahman@liverpool.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/

Funders

Funder type

Research organisation

Funder name

United States Agency for International Development (USAID) (USA) - International Rescue Committee, Inc (IRC-PRIDE)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Liverpool (UK)

Alternative name(s)

Universidad de Liverpool

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes